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A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency
This study has been suspended.
First Received: January 20, 2004   Last Updated: January 31, 2006   History of Changes
Sponsored by: Walter Reed Army Institute of Research (WRAIR)
Information provided by: Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier: NCT00076323
  Purpose

This study will evaluate a new and safe testing method for identifying medicines that can cause problems in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. We are looking for volunteers with G6PD deficiency who would be willing to donate blood samples.


Condition Intervention
Glucosephosphate Dehydrogenase Deficiency
Favism
Drug: Primaquine

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title: A New Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:
  • Difference in degree of hemolysis of G6PD(-) red blood cells in treated vs untreated matched samples.

Estimated Enrollment: 14
Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • Normal clinical evaluation
  • Willing and able to make all scheduled visits

Exclusion:

  • pregnant or planning pregnancy
  • Have taken any anti-malarial medication in past month
  • Positive blood tests for HIV and specific types of hepatitis
  • Allergic to primaquine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076323

Locations
United States, Maryland
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
Walter Reed Army Institute of Research (WRAIR)
Investigators
Principal Investigator: Shon A Remich WRAIR, Experimental Therapeutics
  More Information

Additional Information:
No publications provided

Study ID Numbers: WRAIR 992, G6PD
Study First Received: January 20, 2004
Last Updated: January 31, 2006
ClinicalTrials.gov Identifier: NCT00076323     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Institute of Research (WRAIR):
G6PD
Favism
G6PD Deficiency
hemolysis
drug reaction
drug-induced hemolysis

Study placed in the following topic categories:
Primaquine
Metabolic Diseases
Hematologic Diseases
Glycogen Storage Disease
Anemia
Poisoning
Glucosephosphate Dehydrogenase Deficiency
Anemia, Hemolytic
Disorders of Environmental Origin
Glycogen Storage Disease Type I
Antimalarials
Von Gierke Disease
Anemia, Hemolytic, Congenital
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hemolysis
Glucose 6 Phosphate Dehydrogenase Deficiency
Favism
Metabolic Disorder

Additional relevant MeSH terms:
Anti-Infective Agents
Antiprotozoal Agents
Primaquine
Metabolic Diseases
Hematologic Diseases
Glycogen Storage Disease
Food Poisoning
Anemia
Poisoning
Glucosephosphate Dehydrogenase Deficiency
Anemia, Hemolytic
Disorders of Environmental Origin
Glycogen Storage Disease Type I
Plant Poisoning
Pharmacologic Actions
Antimalarials
Metabolism, Inborn Errors
Anemia, Hemolytic, Congenital
Antiparasitic Agents
Genetic Diseases, Inborn
Therapeutic Uses
Favism
Carbohydrate Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on July 02, 2009